BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-308

    MDR report key: 16538126 · Received March 14, 2023

    Report

    Report Number
    1119779-2023-00277
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 5, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF E. COLI AS SALMONELLA OR SHIGELLA BOYDII WHEN USING PHOENIX PANEL NMIC/ID-308 MATERIAL 449282 BATCH 2110833. THE CUSTOMER PROVIDED PHOENIX GENERATED LAB REPORTS BUT DID NOT PROVIDE PANEL RETURNS OR ISOLATES FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS FROM THE COMPLAINT BATCH AND RETENTION PANELS FROM THE SAME MATERIAL (#449282) BUT DIFFERENT BATCH NUMBER WERE TESTED USING QC E. COLI (A25922) AND IN HOUSE E. COLI (IH 18187 AND IH 11421) ISOLATES ON A PHOENIX INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. FOR A TOTAL OF SIX (6) PANELS TESTED. DURING TESTING, ALL 6 PANELS PROVIDED A CORRECT IDENTIFICATION RESULT OF E. COLI. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. THE DIFFICULTY IN DIFFERENTIATING BETWEEN SHIGELLA SPECIES AND ESCHERICHIA COLI, BOTH CLOSELY RELATED MEMBERS OF THE ENTEROBACTERALES GROUP, IS WIDELY KNOWN. ALTHOUGH THESE SPECIES ARE PHENOTYPICALLY VERY SIMILAR, THEY ARE EPIDEMIOLOGICALLY DIFFERENT IN THEIR PRESENTATION OF CLINICAL DISEASE. BECAUSE OF THIS, MANY CLINICAL LABORATORIES WILL INCORPORATE GUIDANCE IN THEIR STANDARD OPERATING PROCEDURES FOR RULING OUT MISIDENTIFICATION OF SHIGELLA SPECIES AND E. COLI BY COMMON IDENTIFICATION SYSTEMS BY CHECKING COLONY MORPHOLOGY AND INDOLE AND MOTILITY REACTIONS. IF, AFTER ASSESSMENT OF ALL AVAILABLE INFORMATION, A CLINICAL LAB IS UNABLE TO CONFIDENTLY REPORT AN IDENTIFICATION BETWEEN THESE TWO SPECIES, THE ISOLATE MAY BE SENT TO A REFERENCE LABORATORY FOR DEFINITIVE IDENTIFICATION. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. THEREFORE, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. BD ENCOURAGES YOU TO CONSIDER THE FOLLOWING PARAMETERS TO OPTIMIZE RESULTS WITHIN YOUR LABORATORY. QC TESTING SHOULD ONLY BE PERFORMED ON 2ND PASS SUBCULTURES AND AVOID USING COLONIES THAT HAVE BEEN SUB-CULTURED MULTIPLE TIMES ISOLATED COLONIES ARE TO BE USED FOR INOCULATION AND CAREFULLY CHECK PURITY PLATES TO ENSURE THE INOCULUM CONSISTED OF ONE ISOLATE TYPE OPTIMUM PERFORMANCE COMES FROM USING FRESH 18-24 HOUR, WELL-ISOLATED COLONIES ENSURE PROPER, SUFFICIENT INOCULUM DENSITY ALLOW BUBBLES TO DISSIPATE AFTER VORTEXING PROPERLY CALIBRATE THE BD PHOENIXSPEC¿ NEPHELOMETER WITH IN-DATE MCFARLAND CALIBRATION STANDARDS USE SWABS WITH MINIMAL FIBER SHED MAKE THE PROPER INOCULUM DENSITY FOR THE INOCULUM SYSTEM SETTING (I.E., IF PREPARING A 0.25 MCFARLAND INOCULUM, ENSURE THAT THE SYSTEM IS SET TO 0.5 INOCULUM MODE) VOLUME OF ID BROTH SHOULD BE VISUALLY ASSESSED FOR ANY OBVIOUS LOW FILLS ENSURE PROPER INCUBATION TEMPERATURE AND ENVIRONMENT USE THE CORRECT MEDIA TYPE AS LISTED AS ACCEPTABLE FOR USE IN THE USER¿S MANUAL (NOTE - IT IS HELPFUL TO DISCLOSE THE MEDIA TYPE AND VENDOR WHEN PROVIDING THE DETAILS OF THE COMPLAINT). HANDLE PANELS BY ONLY TOUCHING THE SIDES; TOUCHING THE FRONT OR BACK OF THE PANELS MAY CAUSE INTERFERENCE IN THE READINGS AND LEAD TO ERRORS FOLLOW USER¿S MANUAL INSTRUCTIONS FOR TIME LIMITS ON POURING INOCULATED ID BROTH INTO THE PANEL AND PLACING THE PANEL INTO THE INSTRUMENT; EXTENDED PERIODS OF TIME OUTSIDE OF THE STATED LIMITATIONS MAY YIELD ERRORS H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-308 IS MISIDENTIFYING E COLI AS SALMONELLA SHIGELLA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THE PHOENIX INSTRUMENT IS MISIDENTIFYING E COLI AS SALMONELLA SHIGELLA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PANEL PHOENIX NMIC/ID-308 IS MISIDENTIFYING E COLI AS SALMONELLA SHIGELLA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THE PHOENIX INSTRUMENT IS MISIDENTIFYING E COLI AS SALMONELLA SHIGELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114840 PANEL PHOENIX NMIC/ID-308 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown